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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P230026 / PAS001 |
| Date Original Protocol Accepted |
08/02/2024
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| Date Current Protocol Accepted |
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| Study Name |
NSA Alpha New Enrollment PAS
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| Device Name |
Lacrosse NSE ALPHA Coronary Dilatation Catheter
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| Clinical Trial Number(s) |
NCT04985773
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This new enrollment study is a prospective, multicenter, single-arm, post-approval study to further evaluate the Lacrosse NSE ALPHA coronary dilation catheter in patients with stenotic coronary artery disease who are suitable candidates for percutaneous transluminal coronary angioplasty. The purpose of the study is to further evaluate the performance of Lacrosse NSE ALPHA for crossing and scoring stenotic lesions in complex lesions, with specific focus on understanding success of lesion crossing after encouraging physicians to plan for the use of extra delivery support in complex (moderate to severely calcified and/or tortuous) lesions. Patients will be consecutively enrolled and at least 30 patients will have both severe calcification and moderate/severe vessel tortuosity. The remaining patients will have lesions with complex characteristics (i.e., lesions characterized on a spectrum of moderate to severe calcification or vessel tortuosity).
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| Study Population |
Patients with stenotic coronary artery disease who are suitable candidates for percutaneous transluminal coronary angioplasty. At least 30 patients with complex lesion characteristics will be enrolled. Outside of the minimum 30 patients enrolled for severe calcification and moderate/severe vessel tortuosity, the remaining patients will maintain complex lesion characteristics i.e., lesions characterized on a spectrum of moderate to severe calcification or vessel tortuosity.
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| Sample Size |
Number of subjects:
At least 100 subjects, including at least 30 subjects with complex lesion characteristics (i.e., lesions with both severe calcification and moderate/severe vessel tortuosity), will be consecutively enrolled and followed through discharge. Outside of the minimum 30 subjects with both severe calcification and moderate/severe vessel tortuosity, the remaining patients will have lesions with complex characteristics (i.e., lesions characterized on a spectrum of moderate to severe calcification or vessel tortuosity).
Assumptions for sample size estimation: N/A
Number of sites: Subjects will be enrolled at up to 10 sites, with no single sire enrolling more than 20% of the total enrollment.
Sites location: U.S.
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| Key Study Endpoints |
Primary Endpoints:
Device procedural success, defined as:
- Successful delivery, inflation, deflation, and withdrawal of the study balloon; and
- No evidence of device-related vessel perforation, flow limiting dissection (grade C or higher, per Clinical Events Committee [CEC] adjudication) or reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline (per core laboratory assessment); and
- Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure (per core laboratory assessment).
This endpoint will be presented as the proportion of subjects experiencing device procedural success. The proportion of target lesions meeting the primary endpoint will be concurrently calculated and presented as a secondary endpoint, as noted below.
The following Subgroup and Sensitivity Analyses will be performed for the primary outcome:
- Lesion complexity (overall); by operator grading and angiography (per core laboratory assessment)
- Support catheter use (overall)
- Support catheter use in complex lesions
Secondary Endpoints:
12. Angiographic procedural success, defined as final diameter stenosis less than or equal to 50% in at least one of the Lacrosse NSE ALPHA attempted lesions following completion of the interventional procedure, including adjunctive stenting (per core laboratory assessment).
13. Major adverse cardiac events (MACE) through hospital discharge (per CEC adjudication). MACE is defined as a composite of:
- All-cause death
- Myocardial infarction
- Clinically indicated target lesion revascularization
14. Stent thrombosis within the target vessel(s) through hospital discharge using ARC-2 definitions for definite and probable (per CEC adjudication).
15. Clinically significant arrhythmia (defined as those requiring intervention) through hospital discharge (per CEC adjudication).
16. Occurrence of Lacrosse NSE ALPHA balloon rupture (per device deficiency electronic case report form [eCRF]).
17. Change in minimum lumen diameter following use of Lacrosse NSE ALPHA catheter, measured by quantitative coronary angiography (per core laboratory assessment).
18. Device procedural success defined as for the primary endpoint, calculated and presented per target lesion.
19. Rate of device success and failure to cross lesions, including how this may relate to specific lesion characteristics (i.e., calcified and/or torturous).
20. Number of crossing attempts with the device, if any complications with crossing are observed.
21. Details regarding the use of support catheters and/or additional devices to enable lesion crossing after failure from use of device.
22. Physician a priori evaluation of crossing complexity.
Secondary endpoints 1 through 5 are defined at the subject level and will be presented as the proportion of subjects experiencing the above events. In cases where multiple events per subject may be observed (e.g., adverse events), the main analysis will be at the subject level, but total event counts will also be reported. Secondary endpoints 6 through 11 are defined at the lesion level and statistical analyses of these endpoints will account for within-subject correlation as some subjects will have more than one target lesion, using generalized estimating equations with an exchangeable correlation structure.
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| Follow-up Visits and Length of Follow-up |
The overall study duration, from screening the first patient to the final follow-up visit, data analysis, and final report, is expected to be approximately 27 months.
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